US9155734B2ActiveUtilityA1

Stability of hydromorphone hydrochloride solutions

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Assignee: MALLINCKRODT LLCPriority: Mar 7, 2012Filed: Mar 6, 2013Granted: Oct 13, 2015
Est. expiryMar 7, 2032(~5.7 yrs left)· nominal 20-yr term from priority
A61P 25/04A61K 9/08A61K 31/485A61K 9/0085A61K 9/0019
80
PatentIndex Score
4
Cited by
64
References
8
Claims

Abstract

The present invention relates generally to a sterile hydromorphone hydrochloride solution that is substantially free of buffer.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 25° C. and 60% relative humidity for at least 3 months. 
     
     
       2. The composition as recited in  claim 1 , wherein said composition is suitable for intrathecal delivery. 
     
     
       3. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 30° C. and 65% relative humidity for at least 3 months. 
     
     
       4. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 40° C. and 75% relative humidity for at least 3 months. 
     
     
       5. The composition as recited in  claim 1 , wherein said composition is sterilized via aseptic processing. 
     
     
       6. The composition as recited in  claim 1 , having a liquid drug formulation wherein the concentration of hydromorphone hydrochloride is about 10.0 mg/mL. 
     
     
       7. The composition as recited in  claim 1 , having a liquid drug formulation wherein the concentration of hydromorphone hydrochloride is about 2.0 mg/mL. 
     
     
       8. A method of treating pain, the method comprising: intrathecal delivery of the pharmaceutical composition of  claim 1  to a patient.

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